Remediation Consulting, LLC brings understanding of particular criteria for this class of medical devices, including but not limited to:

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• 21 CFR requirements (e.g. Parts 803, 807, 809, 820, 862, 864, 866, et. al.) and ISO criteria

• Clinical Laboratory Improvement Amendments (CLIA)

• Pre-market approval (PMA) and 510K  submission requirements and processes

• Investigational Device Exemptions (IDEs) in support of PMA and 510K submissions

• CE mark qualification needs

• Guidance to Industry - FAQs for In-Vitro Diagnostic Device Studies

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"Diagnosis is not the end, but the beginning of practice."  -  Martin H. Fischer

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